| CTRI Number |
CTRI/2025/12/098373 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
02/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A 12-Month Comparison between two tooth coloured crowns used in children |
|
Scientific Title of Study
|
Comparative Evaluation of Composite Based Pediatric Esthetic Crowns and Zirconia Crowns A 12 Month Follow up Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NARESHVIKRAMAN V |
| Designation |
Postgraduate Student |
| Affiliation |
Madha dental college and hospital |
| Address |
1/313B, Melaveethi, indian bank opposite, thalaivasal, attur, salem district.
somangalam main road, madha nagar, kundrathur, sikkarayapuram, chennai-69
Chennai
TAMIL NADU
636112
India |
| Phone |
80723532012 |
| Fax |
|
| Email |
nareshvikramanv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhan C G |
| Designation |
Professor |
| Affiliation |
Madha dental college and hospital |
| Address |
Madha dental college and hospital, somangalam main road, madha nagar, kundrathur, Sikkarayapuram, chennai-69
Kancheepuram
TAMIL NADU
600069
India |
| Phone |
9486846534 |
| Fax |
|
| Email |
madhancg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NARESHVIKRAMAN V |
| Designation |
Postgraduate Student |
| Affiliation |
Madha Dental College and Hospital |
| Address |
1/313B, Melaveethi, indian bank opposite, thalaivasal, attur, salem district.
Madha dental college and hospital, somangalam main road, madha nagar, kundrathur, sikkarayapuram, chennai-69
Kancheepuram
TAMIL NADU
636112
India |
| Phone |
8072532012 |
| Fax |
|
| Email |
nareshvikramanv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madha Dental College and Hospital,Somangalam main road, madha nagar, Kundrathur, Sikkarayapuram, Chennai-600069 |
|
|
Primary Sponsor
|
| Name |
NARESHVIKRAMAN V |
| Address |
1/313B, Nagalakshmi store, Melaveethi, Indian bank opposite, Thalaivasal, Attur, Salem- 636112, Tamilnadu, India
|
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr NARESHVIKRAMAN V |
Madha Dental College and Hospital |
Room no. 13, Department of Paediatric and Preventive dentistry
Kancheepuram
TAMIL NADU |
08072532012
nareshvikramanv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Madha Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K14||Diseases of oral cavity and salivary glands, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Edelweiss crowns |
Edelweiss crowns are newer crowns introduced in pediatric dentistry which are prefabricated composite resin crowns manufactured using a laser-sintered nano-hybrid composite shell. They are designed for full-coverage restoration of primary teeth. The crowns have a pre-polymerized, highly polished, and wear-resistant surface, allowing chairside customization through bonding techniques. The procedure involves minimal tooth preparation followed by bonding with light-cure composite resin. The intervention includes placement of Edelweiss prefabricated composite crowns on indicated primary teeth following standard manufacturer guidelines. |
| Comparator Agent |
Zirconia crowns |
Zirconia crowns are prefabricated monolithic zirconium oxide ceramic crowns designed for full-coverage esthetic restoration for primary teeth past 15 years. These crowns are known for superior strength, fracture resistance, and excellent esthetics due to their tooth-colored, glazed surface. Placement requires passive fit, with tooth preparation aimed at circumferential reduction and occlusal clearance without internal adjustment of the crown.These crowns serve as a well-established benchmark material against newer restorative options of esthetic crowns such as Edelweiss composite crowns can be compared for effectiveness and long-term success. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Patient between the age group of four to eight years.
Primary molars requiring full coverage restoration following pulpectomy or
pulpotomy.
Healthy children free of any systemic disease or any developmental disturbances
of teeth. |
|
| ExclusionCriteria |
| Details |
Child with parafunctional habits.
Teeth with internal resorption.
Teeth with inadequate crown structure.
Infection involving the furcation areas
Tooth with more than two-third of root resorption |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The integrity of the restoration after 12 months” or “failure rate of crowns”. |
1 YEAR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes include color match, gingival health, marginal adaptation, or patient satisfaction. |
1 YEAR |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present in vivo study aims to clinically evaluate and compare the performance of composite-based pediatric esthetic crowns with that of zirconia crowns in primary molars. The primary objective is to assess the anatomic form, integrity of restoration, color match, and other clinical parameters over a one-year period. The study includes two groups: Group A comprising Edelweiss composite crowns and Group B comprising zirconia crowns, with each group consisting of twenty-five samples. Children aged 4 to 8 years who require full-coverage restorations following pulpotomy or pulpectomy and are otherwise healthy without systemic diseases or developmental dental disturbances will be included in the study. Exclusion criteria include children with parafunctional habits, teeth exhibiting internal resorption, inadequate crown structure, furcation involvement, or more than two-thirds root resorption. All crown placements will be carried out by a single operator to ensure consistency in clinical procedures. The clinical success of the restorations will be evaluated by a single calibrated examiner through visual examination using modified USPHS criteria. Additional parameters such as opposing tooth wear, gingival inflammation, and plaque accumulation will also be assessed at intervals of 3, 6, 9, and 12 months. This study seeks to determine whether composite-based esthetic crowns offer comparable or superior performance to zirconia crowns in terms of esthetics, function, and biological compatibility over a one-year evaluation period. |